Tag Archives: iso 9001:2015 documents

One of the most important checking tools in a Quality Management System (QMS), is the internal audit. The requirements of ISO 9001:2015 are very clear that this is a critical element of your QMS; and, as you want to know how your processes work, your internal audits become a key resource. ISO 9001:2015 Audit Checklist are a widely used and important tool to insure that when performing an internal audit.

What is the ISO 9001: 2015 standard required by the internal audit?

To better understand the why and how of internal audit checklists, it is helpful to understand what the ISO 9001:2015 requirements state about why we do internal audits. The ISO 9001:2015 internal audit is there to perform two functions:

to make sure that the processes are meeting the planned arrangements that the company has identified for the process in the QMS and any requirements that the IOS 9001:2015 standard has in place for that process

to make sure that the process is effectively implemented and maintained

So, when creating ISO 9001:2015 audit checklists, you want to include the information needed to verify these two process results correctly.

How to create an ISO 9001:2015 Audit Checklists to check conformance?

An internal audit is there to witness the outcome of a process through a review of records or witnessing the actions of the employees, and to then compare this to the planned arrangements for the process to see if what is being done is what was planned. As can be seen above, there are two sets of planned arrangements to check: those required by ISO 9001:2015 and those that the company has put in place for their process to work.

An audit checklist is basically a set of questions that the auditor wants to ask, or activities that the auditor wants to witness, in order to verify the planned arrangements as above. The checklist is created by reviewing the ISO 9001:2015 standard and any documented procedures or undocumented processes for the activity to determine what should happen. The ISO 9001:2015 audit checklist could include questions on supplier evaluation and a review of the supplier audit reports that have been collected to see if they are done when determined by the QMS.

The checklist can include more than just questions; it can also include statements from the procedures that the auditor wants to check. The checklist is a tool for the auditor, and it is not something that the controlled entity should complete, so any format or questions and statements will be useful for the auditor to ensure that all the important parts of the process are checked will work.

Why have procedures? Some would answer this question by providing very long lists of reasons why, these lists are sometimes not useful. They are too long to remember and absorb them, and there is too much overlap and redundancy. There are four very basic reasons that demonstrate why we should develop procedures to document important process.

Compliance

Operational Needs (i.e. consistency)

Manage Risks

Continuous Improvement

What to cover in Mandatory ISO 9001:2015 Procedures?

These mandatory ISO 9001:2015 procedures are specified by ISO 9001 and are included in quality manual template. There are the six procedures that are mandatory to be documented. Organization need to ISO 9001:2015 document these six procedures. This doesn’t mean simply will go away with just these six, the ISO 9001:2015 procedures you wish can abundantly rely upon the scale and complexness of your organization, these six but are those that you simply should have.

Six Mandatory ISO 9001:2015 Procedures

1. Control of Documents:

In this ISO 9001:2015 procedure, a written procedure to control the approval and re- approval of procedures and ensuring that the current revision status is displayed. It is the process to ensure that the obsolete documents are controlled and legible and that documents are intended for the external parties such as their clients or the process owner. The documents must be approved by senior management

2. Control of Records:

This is the procedure for checking the archiving of identification, protection, storage and deletion of records by the owner of the process and also keeping records in a specific location. The established records will be checked to provide confirmation of compliance with the requests and the effective functioning of the quality management system.

3. Internal Audit:

The purpose of the ISO 9001 internal audit is to assess the effectiveness of the quality management system and the organization’s overall performance. Your internal audits demonstrate compliance with planned arrangements, e.g. QMS manual, procedures or process maps and that the planned arrangements are implemented and maintained.

4. Control of Non-Conforming Product:

As regards the ISO 9001 standard, the documents are necessary and the records of the non-conformity problem are kept in order to identify them and act in this way. This is a procedure that ensures that the testimonial of the useless product and no action is performed and documented procedure is established to define the controls and the related responsibilities and authorities to deal with non-compliant products.

5. Corrective Action:

A corrective action should be considered as a reactive response to a problem since it is taken when a non-conformance is detected or upon receipt of a customer complaint or other event. Your organization should first contain the problem and then determine its root cause in order to take appropriate corrective action to prevent the problem’s recurrence.

6. Preventive Action:

The Preventive actions are pro-active – something could go wrong and these are actions taken to prevent it from happening, or to prevent it from becoming too severe. If something has already gone wrong, it is a non-compliance that is addressed with corrective actions. ISO 9001: 2015 requires documenting the preventive action procedure. Furthermore, it is necessary to keep a record of the identified preventive actions and actions taken.

At some point during your implementation of an ISO 9001 Quality Management System (QMS), it will be necessary to write some QMS policies and procedures. While it is useful and important to make sure you don’t have too much documentation, there are definitely some policies and procedures that need to write down to avoid non-compliance. For this reason, it is necessary to have a standard way in your organization to write these ISO 9001:2015 documents in a way that is consistent and easy to understand.

1. Decide on the process limits.
After deciding that a process needs to be documented in ISO 9001:2015 procedures, you first need to know the limits of the process you are documenting. Knowing the limits of the process will help you to know when to stop documenting.

2. Collect the information
There are different ways to view a process, but making sure you understand the whole process is important to ensure that nothing is missed, even if you don’t need to document everything. Regardless of how you choose to observe the process, be sure to observe all aspects of the process when gathering information for ISO 9001 documentation.

3. Align with other documents & processes.
Aligning with other processes is very important, and making these interactions work well is one of the best ways to make the whole system more efficient. One place to focus your attention is the inputs and outputs of the process. For the inputs, does the process that creates the input know the requirements of the process using it, or might they change the input later? For the process output, is it used somewhere as an input? If not, then you need to question if this output is actually necessary.

4. Define your document structure.
There are many different ways to document a procedure. For example, you can choose to have documentation that is a series of paragraphs, or you can choose to have a procedure that is in a flowchart format. Regardless, many companies have a standard document structure to help people know where to look for certain important pieces of information, such as the applicability of the document. Knowing where to look for the information needed can save employees time and improve the efficiency of the QMS documentation.

5. Write your document.
Take what you have found and write enough detail that competent people reading it can perform the job required without causing non-conformances. This is the reason you have a document. Adding unnecessary information will not only make your ISO 9001:205 document more cumbersome, it could also confuse your audience.

6. Get approval for your document.
In all cases, you need to make sure the right people approve a document for use. This could be the production manager for production procedures or the purchasing manager for purchasing procedures. A good QMS will define who need to approve which documents so that the right experts are ensuring that the procedure is correct.

7. Train the relevant employees.
It is best to find some way to make sure that the people who need to use a procedure have not only read it, but also understand and have implemented any changes into the process. This can be done through audits or even questioning employees to make sure they understand the important parts of a procedure. In this way, it is also possible to verify the effectiveness of the documented procedure to verify if it is necessary to make some improvements.

ISO 9001 defines the requirements for Quality Management System. ISO 9001 can be used by any organization – large or small, whatever their field of activity. The revised ISO 9001 is published in September 2015 as ISO 9001: 2015. Revised QMS 9001: 2015 standard is based on a number of quality management principles including a strong focus on customers, motivation and involvement of top management, the process approach and continual improvement.

Earlier versions of the ISO 9001 standard were very prescriptive, with many requirements and procedures documented records. In the 2000 edition and 2008, ISO 9001 focuses more on process management and less on documentation but now in the latest version of ISO 9001, is less prescriptive than its predecessor, focusing on QMS 9001:2015 documented information and performance for more quality assurance.

ISO 9001:2015 Certification has major changes in earlier version for effective Quality management system as follows.

The process approach from the 2000 and 2008 versions of ISO 9001 has been maintained in the ISO 9001: 2015.

Introduction of thought based on risk throughout the norm – the term “preventive action” was removed. The entire series is focused on preventing bad things from happening and to look for ways to leverage new opportunities such as new technologies.

Leadership: The ISO 9001:2015 certification imposes requirements on top management demonstrate their commitment to the QMS by taking responsibility for the effectiveness of the QMS, establishing policies, objectives and promoting continuous improvement.

Planning: When planning the QMS, the organization will need to consider internal and external issues and the needs and expectations of stakeholders.

Support: The organization shall determine and provide the necessary resources to establish, implement, maintain and continually improve the QMS.

Operation: In this context OMS 9001 deals with the implementation of plans and processes that allow the organization to meet their quality policy and quality objectives.

Performance evaluation: This sublime clause all the requirements of monitoring and measurement related to the performance and efficiency of their QMS quality.

Improvement: The organization must identify improvement opportunities to continuously improve quality management system of the body.

The following steps should be carried out for ISO 9001:2015 Certification:

Preparation of committee, that has basic knowledge before implementation.